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Drug-Coated Balloon Therapy — Optilume

Optilume® (Urotronic, Inc.) is a paclitaxel-coated drug-coated balloon (DCB) — the FDA-approved antimitotic device for urethral stricture disease. It combines mechanical urethral dilation with localized paclitaxel delivery to inhibit fibrosis and reduce stricture recurrence. The US label covers symptomatic anterior urethral strictures ≤3 cm in adult men. The AUA Urethral Stricture Disease Guideline Amendment 2023 permits its use for recurrent bulbar urethral strictures <3 cm in patients who have failed prior DVIU or dilation; this guideline selection is narrower than the FDA label.[1][2][18]

This article is the device-level deep-dive: mechanism and preclinical tissue pharmacology, the complete ROBUST trial program (I / III with 5-year and 3-year extensions), procedural technique, off-label use patterns from the Sugrue 2026 international survey, and device-specific safety including the Gao 2025 pudendal-artery case. For the class-level comparison against MMC, HA/CMC, PRP, and other adjuncts, see Antimitotics & antifibrotics. For the clinical condition, see Urethral stricture.

Device description and mechanism​

The Optilume DCB is a urethral dilation balloon coated with paclitaxel — a microtubule-stabilizing taxane that produces antiproliferative and antifibrotic effects by preventing cell division, inhibiting fibroblast proliferation, and reducing collagen deposition.[2][3]

Preclinical tissue pharmacology​

  • Will 2011 — paclitaxel 10–100 nM significantly inhibits urinary-tract smooth-muscle cell proliferation and type III collagen production without cytotoxicity to smooth-muscle cells[3]
  • Barbalias 2018 rabbit urethral model — paclitaxel distributes to all urethral layers (urothelial, submucosal, and smooth-muscle) immediately after DCB inflation; drug and mild inflammation persist at 24 and 48 hours[4]
  • Liourdi 2015 porcine ureteral model — paclitaxel penetrates through urothelium to submucosa and muscle by 12–24 hours, with reduced inflammation compared to conventional balloon dilation[5]

The dual mechanism — immediate mechanical dilation for symptom relief combined with sustained local drug delivery to prevent fibrotic recurrence — is what distinguishes the DCB from plain balloon dilation or DVIU.[2]

Available sizes​

Multiple sizes exist; the 24F/3 cm DCB has been associated with higher recurrence rates in real-world data (see below).[6]

ROBUST I — single-arm long-term durability​

Timepointn evaluableFunctional successFreedom from reinterventionIPSS (baseline → f/u)Qmax change
2 y4670%—25.2 → 6.9 (p < 0.0001)Significant ↑[7]
3 y4367%77%25.2 → 5.5 (p < 0.0001)Significant ↑[8]
5 y43 in functional-success analysis; 31 completed follow-up58%71.7% (KM)25.2 → 7.2 (p < 0.001)5.0 → 19.9 mL/s (p < 0.01)[9]

Cohort profile: men with recurrent bulbar strictures ≤2 cm (mean 1.7 prior dilations; 43% with >1 prior dilation). At 5 years, Optilume maintained 71.7% freedom from repeat intervention. Mean erectile-function scores did not deteriorate and no serious treatment-related AEs were observed across the entire 5-year study period.[9]

ROBUST III — pivotal multicenter RCT​

The pivotal multicenter single-blind RCT that supported FDA approval.[10]

Design​

  • 127 patients at 22 sites; recurrent anterior strictures ≤3 cm, ≤12F, ≥2 prior endoscopic treatments, IPSS ≥11, Qmax <15 mL/s
  • Randomized to Optilume DCB vs standard endoscopic treatment (DVIU or dilation)

Outcomes​

EndpointOptilume DCBControlp
Anatomical success at 6 mo (≥14F)75%27%0.001
Freedom from reintervention at 1 y83.2%21.7%<0.001
Freedom from reintervention at 3 y71%——

3-year extension (Srikanth 2025)[11]​

  • DCB arm maintained 71% freedom from reintervention at 3 years. The extension does not provide a contemporaneous randomized three-year control comparison.
  • Clinically significant subgroups (≥5 prior dilations, strictures ≥2 cm) showed no statistically detected differences; these exploratory subgroups do not establish equivalent efficacy
  • Crossover cohort (control patients who failed standard treatment and opted for DCB) produced a Kaplan-Meier curve closely resembling the original DCB cohort; the crossover analysis is not a new randomized comparison

AUA guideline positioning​

AUA 2023 Statement 11b allows dilation or DVIU combined with a drug-coated balloon for recurrent bulbar strictures <3 cm (conditional recommendation; evidence grade B). It does not establish routine first-line or repeat-DCB treatment.[1]

FDA labeling is a separate question: the US indication is symptomatic anterior strictures ≤3 cm in adult men, without a recurrent-only or bulbar-only restriction. Penile or primary anterior treatment meeting those criteria is within the anatomical label but has less established evidence than recurrent bulbar disease. Posterior/BNC/VUAS treatment is off-label.[18]

Procedural technique​

Use the current regional manufacturer IFU for the exact catheter. Trial protocols and surveys describe practice; they do not supersede the device instructions.[18][13]

StepDetail
AnesthesiaGeneral (58% in the Sugrue 2026 survey) or local / sedation
CystoscopyConfirm stricture location and length
Pre-dilationTo ~20F using a standard balloon or sequential dilators
Optilume inflationChoose balloon diameter/length for the stricture and adjacent urethra; hydrate coating ≥60 seconds, then inflate ≥5 minutes without exceeding the size-specific rated burst pressure
Post-procedure catheter12–14F Foley for at least 2 days, or longer standard of care per US IFU
Follow-upUroflowmetry, IPSS, cystoscopy per institutional protocol

Practice-variation signal — Sugrue 2026​

International survey of 102 Optilume users revealed significant practice variation in catheter duration, perioperative antibiotic use, and postprocedure contraception advice — reflecting the early-adoption phase of this technology.[13]

Use beyond the best-supported trial population​

The Sugrue 2026 survey (n = 102) documents use beyond the AUA guideline population. The AUA issues recommendations, not regulatory approvals; the label distinction below follows the US IFU:[13]

Use pattern% of surveyed urologists
Penile urethral strictures (anterior label if other criteria met; limited subgroup evidence)65%
Primary / first-line treatment (not excluded by anterior label; evidence gap)64%
Bladder-neck stenoses (off-label)65%

Higher-volume users (≥10 / y) were more likely to perform DCB under flexible cystoscopy (OR 5.14), for bladder-neck strictures (OR 4.66), and for recurrences (OR 6.92).[13]

Posterior urethral stenosis (BNC / VUAS)​

Berg 2025 retrospective comparative study (n = 141) — DCB dilation significantly improved recurrence-free survival vs standard endoscopic treatment (p = 0.013); treatment modality confirmed as significant predictor on multivariate analysis (HR 0.40; 95% CI 0.19–0.87; p = 0.021). Qmax improved from 9 → 22 mL/s (p = 0.001).[14]

Membranous / sphincteric strictures​

Jelisejevas 2025 (n = 53 — 35 membranous strictures, 18 VUAS extending into the sphincter) — Optilume DCB dilation produced 66.6% freedom from recurrence at median 13.3-month follow-up with no de novo incontinence, an important finding given the proximity to the external urethral sphincter.[12]

Penile urethral strictures​

Salem 2025 small multicenter series (n = 8) — median IPSS 25.5 → 5.0 (p < 0.01); very small uncontrolled series, insufficient to establish routine penile-stricture efficacy.[15]

Real-world 319-patient TURNS experience​

Patel 2025 — anterior strictures 78.4% and posterior stenoses 75.8% 1-year recurrence-free survival. Independent predictors of recurrence:[6]

  • Strictures after hypospadias repair — HR 5.21 (95% CI 1.06–25.6; p = 0.042)
  • 24F/3 cm DCB use — HR 3.64 (95% CI 1.10–12.09; p = 0.035)

Anatomical recurrence-free survival was lower than functional (66.4% anterior / 59.4% posterior) — some patients tolerate mild anatomical recurrence without functional impairment.[6]

FIRST-CARE — the pending first-line RCT​

FIRST-CARE (NCT06827210) — multicenter, single-blind RCT enrolling 140 treatment-naïve patients with single bulbar urethral strictures ≤3 cm to evaluate Optilume DCB as first-line treatment vs standard endoscopic management. Primary endpoint: freedom from repeat intervention at 12 months. This trial directly addresses the first-line-use evidence gap; the protocol does not yet establish a first-line benefit.[17]

Safety profile​

ConcernEvidence
Common AEsUTI, post-procedural hematuria, dysuria — generally mild and self-limited[9][10]
Serious treatment-related AEsNone reported in ROBUST I through 5 years; rare in ROBUST III[9][10]
Erectile functionNo deterioration detected in measured group scores through reported follow-up; not a guarantee for an individual[9][11]
ContinenceNo de novo incontinence in the Jelisejevas 2025 sphincteric-stricture series[12]
Rare vascular injuryOne case report (Gao 2025) of recurrent massive urethral bleeding requiring selective embolization of the internal pudendal artery after Optilume use in a post-urethroplasty recurrence[16]
Systemic paclitaxel concernsLocal delivery minimizes systemic exposure; no systemic paclitaxel-related toxicity reported[4][5]
Contraception — required counselingAbstain from sex or use condoms for 30 days. Men with partners of childbearing potential should use highly effective contraception and avoid fathering a child for at least 6 months; paclitaxel can persist in semen.[18]
Contraindications / infectionUS contraindications include paclitaxel-related hypersensitivity and urologic implants such as penile implants or AUS. Resolve active UTI before treatment.[18]

Limitations and unanswered questions​

Several key evidence gaps remain:[2][6][13]

  • Durability in complex or longer strictures (>3 cm) is uncertain
  • Repeated DCB use has not been validated and is not recommended by the AUA
  • Post-urethroplasty recurrence — the role of DCB as salvage therapy requires further investigation (the Gao 2025 bleeding case occurred in this setting)
  • Penile urethral strictures — the ROBUST III trial was not powered for this subgroup; the anterior label does not establish efficacy for this subgroup
  • First-line use — awaiting FIRST-CARE results
  • Cost-effectiveness — described as "cost-effective" in reviews, but formal health-economic comparisons vs urethroplasty and repeated DVIU are limited
  • Long-term oncologic safety — theoretical concern regarding paclitaxel's effects on urethral tissue over decades; no malignant transformation observed to date

Evidence Summary​

DomainEvidence levelKey source
FDA label / guidelineRegulatory indication / conditional guideline recommendationUS IFU; AUA 2023 Statement 11b[1][18]
Pivotal RCTLevel 1ROBUST III — Elliott 2022[10]; Srikanth 2025 3-year[11]
5-year single-arm durabilityLevel 2DeLong 2025 ROBUST I 5-year[9]
Preclinical tissue PKPreclinicalWill 2011[3]; Barbalias 2018[4]; Liourdi 2015[5]
Posterior stenosis (off-label)Level 3 (comparative retrospective)Berg 2025[14]
Membranous / sphincteric (off-label)Level 3Jelisejevas 2025[12]
Penile strictures (limited evidence)Level 4 (small series)Salem 2025[15]
Real-world 319-patient cohortLevel 3Patel 2025 TURNS[6]
Practice-pattern surveyLevel 4Sugrue 2026[13]
Pending first-line RCTOngoingFIRST-CARE protocol[17]
Vascular-injury caseLevel 5Gao 2025[16]

Clinical Positioning​

  • Use the recurrent bulbar evidence to guide selection, and explain alternatives including urethroplasty. Regulatory anatomy and guideline selection are distinct, as detailed above.[1][18]
  • ROBUST III supports benefit over repeat standard endoscopy in its selected recurrent-stricture population. The three-year extension and ROBUST I five-year single-arm results support durability but do not compare DCB with urethroplasty.[9][10][11]
  • Do not choose a smaller balloon to avoid the 24F association. Observational device-size associations may reflect anatomy and selection; use the IFU sizing method. Hypospadias-associated recurrence estimates are imprecise and warrant individualized counseling.[6][18]
  • Posterior/BNC/VUAS use remains off-label with mainly retrospective evidence. Absence of new incontinence in a small series does not establish safety equivalence or a routine alternative to reconstruction.[12][14]
  • Repeat DCB and routine first-line treatment remain evidence gaps. FIRST-CARE is a protocol, not a positive trial result.[1][17]
  • Follow the device precautions and contraception intervals above. Discuss bleeding, infection and recurrence; the isolated vascular-injury report cannot estimate their incidence.[16][18]

See Also​

Videos​

Drug-Coated Balloon (Optilume)
Operative technique
Drug-Coated Balloon (Optilume)
Operative technique

References​

1. Wessells H, Morey A, Souter L, Rahimi L, Vanni A. "Urethral stricture disease guideline amendment (2023)." J Urol. 2023;210(1):64–71. doi:10.1097/JU.0000000000003482

2. Kapriniotis K, Loufopoulos I, Apostolopoulou A, Anderson PCB, Papaefstathiou E. "Drug-coated balloon treatment for urethral strictures: is this the future? A review of the current literature." J Clin Med. 2025;14(8):2854. doi:10.3390/jcm14082854

3. Will TA, Polcari AJ, Garcia JG, et al. "Paclitaxel inhibits ureteral smooth-muscle cell proliferation and collagen production in the absence of cell toxicity." J Urol. 2011;185(1):335–340. doi:10.1016/j.juro.2010.09.006

4. Barbalias D, Lappas G, Ravazoula P, et al. "Evaluation of the distribution of paclitaxel after application of a paclitaxel-coated balloon in the rabbit urethra." J Endourol. 2018;32(5):381–386. doi:10.1089/end.2017.0935

5. Liourdi D, Kallidonis P, Kyriazis I, et al. "Evaluation of the distribution of paclitaxel by immunohistochemistry and nuclear magnetic resonance spectroscopy after the application of a drug-eluting balloon in the porcine ureter." J Endourol. 2015;29(5):580–589. doi:10.1089/end.2014.0683

6. Patel HV, Erickson BA, Abbasi B, et al. "Early real-world experience with Optilume drug-coated balloon for anterior urethral strictures and posterior urethral stenoses." Urology. 2025. doi:10.1016/j.urology.2025.10.025

7. Mann RA, Virasoro R, DeLong JM, et al. "A drug-coated balloon treatment for urethral stricture disease: two-year results from the ROBUST I study." Can Urol Assoc J. 2021;15(2):20–25. doi:10.5489/cuaj.6661

8. Virasoro R, DeLong JM, Estrella RE, et al. "A drug-coated balloon treatment for urethral stricture disease: three-year results from the ROBUST I study." Res Rep Urol. 2022;14:177–183. doi:10.2147/RRU.S359872

9. DeLong J, Virasoro R, Pichardo M, et al. "Long-term outcomes of recurrent bulbar urethral stricture treatment with the Optilume drug-coated balloon: five-year results from the ROBUST I study." J Urol. 2025;213(1):90–98. doi:10.1097/JU.0000000000004229

10. Elliott SP, Coutinho K, Robertson KJ, et al. "One-year results for the ROBUST III randomized controlled trial evaluating the Optilume drug-coated balloon for anterior urethral strictures." J Urol. 2022;207(4):866–875. doi:10.1097/JU.0000000000002346

11. Srikanth P, DeLong J, Virasoro R, Elliott SP. "A drug-coated balloon treatment for urethral stricture disease: three-year results from the ROBUST III study." J Endourol. 2025. doi:10.1089/end.2024.0718

12. Jelisejevas LA, Tulchiner G, Rehder P. "Optilume drug-coated balloon dilation for male sphincteric (membranous) urethral strictures: 53 consecutive cases." J Clin Med. 2025;14(23):8369. doi:10.3390/jcm14238369

13. Sugrue DD, O'Connor J, Białek Ł, et al. "Practices in urethral stricture management with drug-coated balloon dilatation: an international survey." World J Urol. 2026;44(1):285. doi:10.1007/s00345-026-06343-y

14. Berg EK, Mehmedovic S, Askari D, et al. "Efficacy of drug-coated balloon dilation vs endoscopic standard treatment in posterior urethral stenosis: a real-world comparative study." Urology. 2025. doi:10.1016/j.urology.2025.07.034

15. Salem J, Menendez-Suarez JJ, Tosev G, Borgmann H, Kuru T. "Efficacy and mid-term outcomes of paclitaxel-coated balloon (Optilume) for penile strictures." J Clin Med. 2025;14(17):6022. doi:10.3390/jcm14176022

16. Gao Y, Mukherjee S, Aydin A, Shekho M, Winkler M. "An unusual case of recurrent massive urethral bleeding following Optilume urethral dilatation needing selective embolisation of the bleeding vessel." Ann R Coll Surg Engl. 2025. doi:10.1308/rcsann.2025.0088

17. Mahdi MB, Haase RN, Sander L, et al. "Treatment of bulbar urethral strictures with Optilume drug-coated balloons in a previously untreated population (FIRST-CARE): protocol for a single-blind multicentre randomised controlled trial." BMJ Open. 2026;16(1):e103948. doi:10.1136/bmjopen-2025-103948

18. Urotronic. Optilume Urethral Drug Coated Balloon Catheter: US Instructions for Use, 1111-003 Rev B. Current manufacturer-hosted US IFU accessed September 12, 2026. Instructions for use.